21 CFR 862.1690 — Radioimmunoassay, Thyroid-Stimulating Hormone

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1690

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JLWRadioimmunoassay, Thyroid-Stimulating Hormone22423rd Party
Innolitics

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